BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.85MM TI MATRIX SCREW SELF-DRILLING

    MDR report key: 2200730 · Received April 14, 2011

    Report

    Report Number
    1719045-2011-00186
    Event Type
    Injury
    Date Received
    April 14, 2011
    Report Date
    December 28, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. BRAND NAME OF DEVICE IMPLANTED IN PT WAS 1.85MM TI MATRIX SCREW SELF-DRILLING 4MM (CATALOG NUMBER 04.511.224.05) AND 1.85MM TI MATRIX SCREW SELF-DRILLING 5MM (CATALOG NUMBER 04.511.226.05). THE QUANTITY OF THE TWO CATALOG NUMBERS IS UNK AND IT IS UNK AS TO WHICH SCREW WAS USED WITH THE ASSOCIATED PLATES. CATALOG NUMBERS 04.511.224.05 AND 04.511.226.05 WERE IMPLANTED IN THE PT. IT IS UNK AS TO WHICH SCREW WAS USED WITH THE ASSOCIATED PLATES AND THE QUANTITY OF THE TWO CATALOG NUMBERS OF SCREWS IS UNK. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH ONE MATRIX 90 DEGREE L-PLATE, TWO MATRIX OBLIQUE L-PLATES AND MATRIX SCREWS FOR AN ORTHOGNATHIC PROCEDURE (JAW RECONSTRUCTION). ONE HOUR AFTER THE PROCEDURE WAS COMPLETED, SURGEON FOLLOWED UP WITH PT AND NOTICED THAT THE ENTIRE PLATE/SCREW CONSTRUCT WAS NOT STABLE. TWO OF THE PLATES WERE BROKEN AND THE SCREWS WERE LOOSE AND BACKING OUT. HARDWARE WAS REMOVED AND REPLACED. THIS IS THE 3RD OF 12 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.85MM TI MATRIX SCREW SELF-DRILLING MATRIX SCREW SELF-DRILLING JEY SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| PLATES